MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID, PEGGED ALPHA, SMALL

Model Number	314-02-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): 300-50-15, 5293099 - 1.5mm short rep plate.310-00-41, 3751771 - xs humeral head, 41mm xs offset humeral head.315-35-00, 5552546 - glnd kwire.300-20-02, 5552546 - equinox square torque define screw drive kit.314-13-02, 5310224 - equinoxe cage glenoid small, alpha.300-30-08 , 5572630 - equinoxe preserve stem 8mm.
Event or Problem Description
As reported, approximately 41 months postop the initial right tsa, the (b)(6) y/o female patient was pulling a rug and in a different instance picking up a christmas tree when she felt a sharp pain.Since then has had inconsistent but frequent sharp pain with adls.Surgeon diagnosed as aseptic glenoid loosening.Patient is considering revision surgery.Will be seen back again to further discuss.Outcome: continuing.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported was likely the result of an insufficient bond between the pegged glenoid component and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed because the patient has not been revised at the time of this investigation; therefore, the device are not available for evaluation.

• Brand Name: EQUINOXE
• Common Device Name: GLENOID, PEGGED ALPHA, SMALL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gaiensville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 12431964
• Report Number: 1038671-2021-00461
• Device Sequence Number: 17483007
• Product Code: KWT
• UDI-Device Identifier: 10885862084477
• UDI-Public: 10885862084477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2020
• Device Model Number: 314-02-02
• Device Catalogue Number: 314-02-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/07/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White